Why don’t I need a prescription for LiveO2 or ExtremeO2 ?

Under these reg­u­la­tions are three spe­cif­ic aspects that may cause a device to be reg­u­lat­ed as a med­ical device or phar­ma­ceu­ti­cal drug:

Is it used to diag­nose, pre­vent or treat any dis­ease or health con­di­tion caused by a claim made by the man­u­fac­tur­er — not true for either LiveO2 or ExtremeO2;

It does not achieve its pur­pos­es through chem­i­cal action with­in the body. Respiration is a nat­ur­al and essen­tial process that trans­ports oxy­gen with­in the body — not chem­i­cals.

Oxygen is only clas­si­fied as a drug when used for breath­ingand is admin­is­tered by anoth­er per­son. Self admin­is­tered oxy­gen, as with LiveO2 and ExtremeO2 train­ing, is not admin­is­tered by anoth­er per­son; indi­vid­u­als are free to use oxy­gen as they choose.

The mech­a­nism of LiveO2 and ExtremeO2 prod­ucts is to enhance the nat­ur­al oxy­gena­tion effects of exer­cise. It is well under­stood and gen­er­al­ly accept­ed that exer­cise helps to pre­vent and aid recov­ery from many dis­eases and health con­di­tions.

There is no need to be spe­cif­ic. Neither exer­cise nor exer­cise equip­ment is reg­u­lat­ed by the FDA, even though exer­cise pro­vides a wide range of health ben­e­fits and affects many rec­og­nized health con­di­tions.

About Medical Claims

A claim becomes reg­u­lat­ed when a man­u­fac­tur­er asserts their brand of exer­cise equip­ment has a reg­u­lat­ed health effect on a spe­cif­ic con­di­tion. Here are exam­ples illus­trat­ing the dif­fer­ences:

Medical Advice — Non FDA Regulated: Your doc­tor tells you that rid­ing your Schwinn 5 miles a day will help you pre­vent a heart attack. (Your doc­tor can advise spe­cif­ic exer­cise, includ­ing a spe­cif­ic brand that may be ben­e­fi­cial to you, based on his/her knowl­edge of your phys­i­cal needs.)

The oper­a­tive prin­ci­ple is that a state­ment becomes a med­ical claim when it specif­i­cal­ly asso­ciates a man­u­fac­tur­ers claim to a spe­cif­ic brand regard­ing a spe­cif­ic health con­di­tion in a pub­lic state­ment. The FDA usu­al­ly requires man­u­fac­tur­ers, like Schwinn, in this exam­ple, to sup­port truth of the claim in the form in a clin­i­cal tri­al, or cred­i­ble peer reviewed lit­er­a­ture.

This rule pro­tects con­sumers by pre­vent­ing man­u­fac­tur­ers from mak­ing unsup­port­ed claims regard­ing the health effects of their prod­ucts.

Non Medical Analysis

LiveO2 and ExtremeO2 are exer­cise enhancers. In affect­ing the amount of oxy­gen deliv­ered to your cells dur­ing exer­cise, you can accel­er­ate and improve the results of your exer­cise.

Since the man­u­fac­tur­er in this case choos­es to makes no claims that asso­ciate prod­uct use to any spe­cif­ic health con­di­tion, and because the oxy­gen is self admin­is­tered, this device is deemed non-med­ical.

The sec­ond con­sid­er­a­tion applied by the FDA “risk”. Risk relates to the nature of the risk of prod­uct use, or risks asso­ci­at­ed with prod­uct fail­ure dur­ing use: Here are the cri­te­ria:

Class I devices are not intend­ed to help sup­port or sus­tain life or be sub­stan­tial­ly impor­tant in pre­vent­ing impair­ment to human health, and may not present an unrea­son­able risk of ill­ness or injury. (LiveO2 and ExtremeO2 are NOT intend­ed to help or sus­tain life or be more impor­tant than exer­cise in pre­vent­ing impair­ment to human health);

Class II devices are designed to per­form as indi­cat­ed with­out caus­ing injury or harm to patient or user.

Class III devices are usu­al­ly those that sup­port or sus­tain human life, are of sub­stan­tial impor­tance in pre­vent­ing impair­ment of human health, or present a poten­tial, unrea­son­able risk of ill­ness or injury.

As a Class 1 device, LiveO2 and ExtremeO2would be exempt from pre-mar­ket cer­ti­fi­ca­tion.